CN113271856A - System and method for optimizing bedside insertion and recording functions of a subcalotte electrode array for short-term hemispheric brain monitoring - Google Patents

Abstract

Translated fromChinese

本发明包含允许实现为了放置在帽状腱膜下空间内以记录脑电活动而设计的可植入电极阵列的微创插入和功能优化的系统和方法。可植入阵列包括能够被植入在帽状腱膜下空间中并且包括至少一个参考元件的支撑结构；至少一个地元件；以及一个或多个记录元件；并且其中，所述阵列能够检测和/或发送帽状腱膜下电信号。

The present invention includes systems and methods that allow for minimally invasive insertion and functional optimization of implantable electrode arrays designed for placement within the subgaleal space to record electrical brain activity. The implantable array comprises a support structure capable of being implanted in the subgaleal space and comprising at least one reference element; at least one ground element; and one or more recording elements; and wherein the array is capable of detecting and/or Or send electrical signals under the galeal aponeurosis.

Description

System and method for optimizing bedside insertion and recording functions of a subcalotte electrode array for short-term hemispheric brain monitoring

Technical Field

The present invention comprises systems and methods that allow for minimally invasive insertion and functional optimization of electrode arrays designed for temporary placement within the sub-calophyllal space for recording brain electrical activity. The described systems and methods allow healthcare providers to record and compare clinically relevant bi-hemispherical high fidelity EEG signals in an acute setting even without specialized EEG or surgical training, without the need to apply scalp electrodes or implant recording electrodes in a formal surgical setting.

Background

In the following discussion, certain articles and methods will be described for background and introductory purposes. Nothing contained herein should be construed as an "admission" of prior art. Applicants expressly reserve the right to demonstrate, where appropriate, that the articles and methods cited herein do not constitute prior art, subject to applicable legal regulations.

In many cases of brain injury, timely detection of detrimental changes in brain health status may be critical to effectively treat primary injury or prevent secondary injury. Although a range of nerve monitoring devices have been developed for these purposes, the most effective means of rapidly and directly assessing neuronal health status is electroencephalography (EEG).

Traditional EEG uses a series of metal electrodes attached to the scalp of a patient to record oscillating potentials that are naturally generated by specific cells within the brain. Although EEG has been used primarily for the purpose of detecting abnormal firing of neurons that leads to seizures in the past, data have also supported the use of EEG for real-time monitoring of brain health in both normal and pathological states.

For example, EEG changes are rapidly observed when cerebral blood flow drops below a critical level (cerebral ischemia). In many cases, these changes can be seen before irreversible brain damage (cerebral infarction) develops, which allows health care providers to perform clinical interventions to improve cerebral blood flow and prevent permanent damage. Along these lines, EEG may be extremely beneficial for patients suffering from traumatic brain injury, cardiac arrest, stroke, and other acute neurological conditions in which delayed reversible changes in brain health status may occur, and effective real-time monitoring of brain health status would provide the opportunity for more effective and appropriate clinical intervention.

Despite the major benefits that may be attributed to the use of EEG in patients with acute brain injury, practical factors have significantly limited the widespread adoption and utility of this technology for acute brain injury in clinical settings. Such factors have also limited the development of methods for automated EEG data analysis, which is essential for continuous clinical use in modern times.

Conventional EEG is extremely technically cumbersome. To initiate recording of EEG data, the first step requires the application of a metal-based electrode to the scalp of the patient by a trained technician. This process is time consuming, tedious, and often requires repetition of the process for patients who require prolonged monitoring and undergo various clinical interventions (as electrodes tend to be easily dislodged due to the lack of permanent fixative between the electrode and the skin). Effectively attaching the electrodes to the recording hardware requires many separate wires that are inserted into specific points on the signal amplifier (requiring expertise and experience). This requirement for a large number of individually attached wires creates challenges in rationalizing care and leads to frequent disconnections and caregiver frustration.

An additional technical requirement for standard scalp electrode-based EEG is to record baseline electrical signals using a separate "reference" electrode, against which all other recording channels are measured. This reference electrode is accompanied by a necessary second "ground" electrode which is used to provide common-mode rejection of electrical artifacts generated by hardware or electrical equipment in the local environment. If the reference electrode, ground electrode, or both are improperly positioned or disconnected in some manner, the entire EEG recording becomes corrupted and unusable. Thus, if there are technical problems with the common reference electrode or ground electrode, a trained technician must be available to constantly monitor the fidelity of the EEG recording and provide "troubleshooting" support.

For these reasons, 24 hour availability of well trained technicians is required to effectively utilize scalp-based continuous EEG recordings for brain-injured patients. Unfortunately, most clinical centers do not have financial resources or trained personnel to support this process and therefore are not able to effectively provide continuous 24 hour EEG recordings for brain-injured patients.

In addition to the complex technical requirements associated with long-term scalp electrode-based recording, current clinical use of EEG relies heavily on raw electrical waveform analysis. This process requires the availability of experts trained in the field of EEG interpretation. There are several major limitations associated with the need for such trained experts. First, these individuals typically do not review EEG on a continuous basis; in contrast, records are reviewed on a sporadic basis, which may be as infrequent as once every 24 hours. Since the relevant physiological changes are usually continuous rather than sporadic, such infrequent EEG examinations are hardly useful for monitoring brain health status in patients with neurological impairments. Second, relevant EEG changes identified in a delayed manner are often well noticed after a potentially reversible secondary brain injury has become irreversible, rendering delayed identification of EEG abnormalities clinically insignificant. Third, the number of experts trained in the field of EEG interpretation is relatively rare and not available in many settings where EEG monitoring of brain-injured patients is critical. Finally, no significant amount of information is seen in the raw waveform data that has the greatest utility for monitoring brain-injured patients, and quantitative analysis of EEG "power" in specific frequency bands is required to effectively identify changes of interest.

To this end, it is possible that physiologically useful information can be readily obtained by mathematically processing the raw EEG signal into an easily interpreted visual color display (a "compressed spectral array" displaying EEG power in discrete frequency bands). However, the requirement for a "clean" EEG signal (a signal that benefits from a high signal-to-noise ratio) in such analyses has ultimately mitigated the clinical adoption of quantitative EEG methods using scalp-based electrodes. Current methods require manual supervision to confirm the validity of the processed signal and ensure that periods of contamination from artifacts, noise or loss of electrode contact are not interpreted as valid EEG (which is common in the case of scalp EEG as previously indicated).

Furthermore, contaminated EEG recordings can emerge from several independent sources. On the "signal" side of the equation, the distance from the "generator" (i.e., neuron) of the EEG signal and the presence of interfering tissue (e.g., tissue of the scalp) that attenuates the signal serve to reduce the electrical signal amplitude and increase the "averaging" effect that tends to minimize the overall amplitude of the EEG waveform. On the "noise" side of the equation, the electromechanical factors inherent to recording with scalp electrodes are a significant source of EEG artifacts. As mentioned previously, the fragile connection between the metal and the skin produces the introduction of significant electrical noise and inconsistency of the signal. Sources of external electrical noise are widely distributed in clinical settings (e.g., intensive care units) where care of patients with brain damage typically occurs and can include a range of different environment-based electrical artifacts (contaminating electrical signals from other devices, movement of electrodes or connecting wires during clinical care activities, etc.) and patient-based artifacts (electrical signals generated by muscle activity associated with shivering, skin abnormalities, etc.). Crucially, excessive noise, failure or loss of the common reference electrode will prohibit any useful recording from any additional electrodes throughout the cranium.

In summary, the poor signal-to-noise ratio and poor long-term fidelity of scalp-based EEG systems have hindered the development of efficient automated, continuous, reliable quantitative analysis methods necessary for EEG-based nerve monitoring tools in brain-injured patients. Accordingly, there is a need for a system that allows non-expert clinical personnel to deploy an electrode array that provides continuous high fidelity EEG recording.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other features, details, utilities, and advantages of the claimed subject matter will be apparent from the following written detailed description including those aspects illustrated in the accompanying drawings and defined in the appended claims.

As described herein, one aspect of the present invention is an implantable subcalotenoid electrode array (implantable subcalotenoid electrode array) comprising a support structure capable of passing through the skin and being implanted in the subcalotenoid space. The support structure of the implantable device comprises at least one reference element; at least one ground element; and one or more recording elements. The array is capable of detecting and/or transmitting electrical subcalotte signals.

In a preferred embodiment, a plurality of recording elements are included in the array. In case one of the recording elements becomes inactive and/or fails to transmit an accurate EEG signal, the plurality of recording elements can be used as "spare parts". Furthermore, the orientation of the recording element along the support structure can be varied. For example, the recording elements can be arranged linearly and/or circumferentially along the support structure. In other preferred embodiments, the reference element and ground element can be located at the furthest point of contact from the exit point of the array.

In further preferred embodiments, the reference element and/or ground element are located just proximal to the exit point of the array (e.g., just below the skin). In a further preferred embodiment, the reference elements and ground elements are distributed along the array at a distance from an entry point or exit point of the array. Furthermore, the reference element and/or the ground element can be located on the opposite side array or juxtaposed on the same array. In further preferred embodiments, the reference and ground elements may be present in other configurations than arrays containing recording elements; for example, the reference element, the ground element, or both may be located on another device designed for implantation into or on the patient. The recording elements can be distributed along the array and can be positioned proximal, distal, or mixed with the reference element, the ground element, or both. In a further preferred embodiment, parallel reference and ground electrodes are electrically tied together from each side at the level of the external hardware, thereby producing an "averaged" ground signal and reference signal for subsequent analysis of symmetry. Any of the above combinations are also contemplated.

The support structure of the implantable array must be made of a material capable of accommodating the reference element, ground element and recording element. More importantly, the support structure must be able to be inserted into the sub-calophyllal space and maintained for extended periods of time (ranging from minutes up to weeks). Examples of preferred support structures include, but are not limited to, being cylindrical in shape, made of a flexible biocompatible material (such as, for example, silicone rubber or polyurethane); and/or curved in a shape having a pointed tip (pointed tip). The diameter of the array may be as small as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0mm and as large as 1cm, 2cm or 3cm, but smaller or larger arrays are also possible. Where the array is likely to bend, it is generally intended to follow the natural curvature of the human skull and will therefore be flexible in some cases. These structural features of the support structure facilitate non-invasive passage of the array through the skin and into the sub-calophyllal space.

As described herein, the implantable electrode array can include additional elements for assisting in inserting, positioning, and/or maintaining the array in the sub-calophyllal space. For example, a device associated with an implantable electrode array may further include: a sheath, a needle, and a tubing-assisted attachment, wherein the attachment device is capable of pushing and/or pulling the needle through the sub-tenon space; an insertion guide for identifying an anatomically appropriate region for electrode access; a holding device of the electrode at the skin entry site; a holding means for the electrode at the skin exit site; an exit guide for facilitating passage of the needle through the skin at the exit point; a needle physically associated with, connected to, or otherwise connected to a portion of the electrode array; and/or any combination of the above.

In a preferred embodiment, the electrode array is capable of directionally tunneling in the subcalotte space according to a parasagittal anterior-posterior line (parasagittal electrode-spatial line) overlying one or both hemispheres of the brain.

In other embodiments, the implantable array is part of a system for measuring activity under the aponeurosis. For example, a system for measuring subcalotenoid activity can include an implantable subcalotenoid electrode array as described herein and an interface connecting the implantable subcalotenoid electrode array to a processor. The processor can be configured to perform a number of tasks and calculations, including but not limited to:

a) detecting, filtering, processing, displaying, storing and/or transmitting brain-derived electrical signals in real-time;

b) automating the selection of the reference element and/or the ground element;

c) interrogating the recording functions of the reference element, the ground element and the recording element;

d) filtering and/or processing the detected electrical signals to generate single or multi-channel electroencephalographic (EEG) data, preferably comprising:

(i) raw EEG data; or

(ii) Quantifying EEG data;

e) using a series of displays and recordings of montages (montages), including reference montages and montages derived from electrode pairs;

f) pre-assigning a recording montage to one or more recording elements;

g) reference elements, ground elements, and/or recording elements that demonstrate poor signal quality are preferably continuously monitored, identified, and excluded using techniques such as;

(i) evaluation of absolute voltage;

(ii) evaluation of the voltage relative to other individual or polymeric recording elements;

(iii) evaluation of absolute EEG power;

(iv) evaluation of EEG power relative to other individual or aggregate recording elements;

(v) recording impedance measurements of the element;

h) analyzing and interpreting signals between a plurality of implanted electrode arrays;

i) balancing the montage, preferably by selecting data from particular recording elements to provide symmetry between the arrays;

j) allowing variable or dynamic selection of particular combinations of recording elements on multiple arrays to compose a recording or display montage;

k) performing a bipolar mathematical reference between the recording elements on the array;

l) measuring, analyzing and reporting symmetry, asymmetry or difference analysis between two hemispheres of the brain;

m) any combination of (a) - (l).

Pre-assignment of the recording montage to one or more recording elements can occur through a user-selected combination of implanted arrays or through direct interrogation of received electrical signals/data. Furthermore, by continuously monitoring, identifying and excluding non-functional reference elements, ground elements and/or recording elements allows one to evaluate signal characteristics for each individual recording element and discard data from a particular recording element if that data is deemed non-functional or artificial.

Similarly, by using multiple implanted electrode arrays positioned, for example, bilaterally, one can receive a symmetry analysis of the hemisphere recordings, enabling a symmetry or difference analysis between the two hemispheres of the brain to be generated and evaluated. Further, greater diversity of recorded inter-contact electrical signals is provided by allowing variable or dynamic selection of particular combinations of recording elements on multiple arrays to compose a recording or display montage.

In a preferred embodiment, the electrode array is capable of directionally tunneling in the subcalotte space in a parasagittal anteroposterior line overlying one or both hemispheres of the brain.

In other embodiments, the interface and the processor are integrated into each other or the array, and/or are portable. Additionally, the holding element and/or actuator is integrated with the interface and/or processor.

In further preferred embodiments, an implantable electrode array and/or system as described herein is used to measure brain activity. Brain activity can be measured in a number of conditions including, but not limited to, brain injury, stroke, cerebral hemorrhage, intracranial hemorrhage, hypoxic/anoxic brain injury, such as, for example, as may be seen in the case of cardiac arrest, seizure, critical neurological damage, and/or any medical condition requiring brain monitoring.

In further preferred embodiments, the systems described herein can be used to detect spread suppression of the cerebral cortex.

Furthermore, in further preferred embodiments, the implantable electrode array and/or system as described herein can be used to:

a. measuring brain activity during an intravascular procedure;

b. measuring brain activity during a neurosurgical or vascular surgical procedure;

c. measuring brain activity during a cardiac or other surgical procedure;

d. assessing brain injury in an acute setting, for example, in an ambulance or battlefield;

e. identifying laterality of the brain injury or abnormality;

f. providing diagnostic information about brain health status; or

Any combination of (a) - (f).

Drawings

The objects and features of the present invention can be better understood with reference to the following detailed description and the accompanying drawings.

Fig. 1A and 1B depict the anatomical orientation of a subcalotte electrode array placed in the parasagittal plane according to the medial pupillary line (100) on the right side, extending from the posterior/mural insertion point (110) to the anterior/frontal exit point (120), with the extracranial extension designed for unitized insertion into a connection cable connected to an interface/processor (130). The gray portion of the array is the portion located in the space under the aponeurosis.

Fig. 2 is a graphical "cutaway" representation of the layers of the scalp, including the epidermis (200), subcutaneous tissue (210), the aponeurosis (220), the sub-aponeurosis space (230), and the skull (240), so that the demonstration electrode array (250) is located within the sub-aponeurosis space between the aponeurosis and the skull after having been placed through the skin and subcutaneous tissue (200, 210, 220).

Fig. 3A, 3B and 3C depict needle devices each having an attachment sheath (310) designed for non-invasive passage of an electrode array into the subtropical space. Three different needle examples, 300, 320 and 330, are shown in fig. 3A, 3B and 3C. As illustrated in fig. 3B and 3C, the needle tip may be straight (320) or angled (330) to facilitate passage through the subtropical space. As indicated by the needle portion (340) shown in fig. 3C, the needle itself may be curved to conform to the natural curvature of the skull.

4A, 4B and 4C illustrate the attachment points and manner of use of the needle through the supplemental device relative to the needle and sheath apparatus for positioning of the sub-calophyllum array; there are holes at the front (400) and rear (410) of the needle through which pass assist devices can be placed for "push" (420) and "pull" (430) assistance.

Figure 5 provides a top view of the head with a symmetric bilateral electrode array placed in the subcapillary mid-pupillary line (500) overlying the wall (510) and frontal (520) regions.

Fig. 6A, 6B and 6C demonstrate the nature and means of use of a needle exit guide (600) designed to assist the needle in passing through a proposed exit point from the sub-calotte space.

Fig. 6A is a front view of an exit guide (600) having a solid ring with a central opening (610) for passage of a needle.

Fig. 6B is a side cross-sectional view of the exit guide (600) having a taper in thickness from the outer edge (630) of the central bore (640) to the flange.

Fig. 6C is a top view of the head (650) and demonstrates the needle/sheath device placed through the subcalotte space with the exit guide (600) positioned at the proposed exit point to guide and assist the exit of the needle from the subcalotte space.

Fig. 7A and 7B provide side and top views, respectively, of a needle insertion guide (700) designed to identify the appropriate trajectory (710) at the mid-pupillary line and the entry point (720) at the wall curvature of the skull.

Fig. 8A-8G depict an array retaining device for assisting in securing an array that has been placed into the sub-aponeurosis space.

Fig. 8A and 8B are front and side views, respectively, of an exemplary rear "detent" 805 made up of a small hollow cylindrical central element attached to a larger disk to be attached to the end of the array and designed to prevent the array from being pulled out of the front exit point, which can be placed on the rear end of the array before insertion (820) and secured to the skin after the final recording elements on the array have passed into the sub-tenon's space (830).

Fig. 8C and 8D are front (840) and side (850) views, respectively, of an exemplary anterior "stop" constructed of a disc with a central hole just large enough to accommodate the array passing through the hole and designed to prevent the implanted array from moving back into the sub-aponeurotic space, which can be placed over the front of the array (860) after the array passes through the anterior exit point (870). Staples, sutures or alternative medically appropriate means can be used to secure the holding means to secure them to the skin and once secured in place, the holding means will serve to stabilize the array and maintain sterility in the space under the galena, providing coverage of entry and exit points for entry into the skin.

Fig. 8F and 8G are sequential top views of the head with the electrode array placed in the sub-calophyllal space and illustrate the positioning of the posterior stopper (830) and then the anterior stopper (870) after insertion of the array.

Fig. 9 depicts a unitized assembly with the insertion needle being part of the electrode array (900) and including a retaining element distal to the last recording element designed to secure the array at the entry point into the scalp (910).

Fig. 10A and 10B provide representative examples of digital channel assignments for a double-sided, capped sub-aponeurotic electrode array including ground elements (numerals 10 and 20), reference elements (numerals 9 and 19), and individual recording elements (remaining contacts).

Fig. 11A and 11B provide representative examples of channel assignments for a single-sided, inferior aponeurotic array comprising a ground element, a reference element, and a separate recording element, in which case an alternative arrangement of reference element (numeral 5) and ground element (numeral 10) positioning is used in relation to the remainder of the recording elements on the array.

12A, 12B, and 12C depict strategies for selecting recording channel pairs to generate a synthetic channel in a bipolar recording montage. In fig. 12A, the composite channel is generated by bipolar comparison of the recordings from adjacent channels, resulting in a total of 7 composite channels. FIG. 12B represents the "skip one" approach whereby the composite channel is generated by a bipolar comparison of every other recording element along the array. Similarly, FIG. 12C represents a "skip two" approach whereby the composite channel is generated by a bipolar comparison of every third recording element along the array. The "skip" synthesis channel can thus be used to provide electrophotographic sampling of a larger recording field.

Fig. 13 provides a side view of a subcalotte array of integrated needle and actuator devices (1300) with a single entry point (1310) inserted and secured in the frontal region without the need for a secondary exit point. The gray portions of the array indicate the portions located in the sub-aponeurosis space.

Fig. 14 depicts an example of a balancing function of the processor that allows data symmetry between two hemispheres of the brain to be maintained if individual recording elements at a particular point along a single array are identified as "bad". In this representative example, data from a two-sided array, each including four recording elements, is utilized. When a particular data channel is identified as "bad" on an array (in this case, a series of "bad" channels on the right), the processor provides for the simultaneous exclusion of: 1) a synthetic bipolar recording channel derived from montage on the affected side (ipsilateral/right) containing "bad" recording elements, and 2) a synthetic bipolar channel derived from matching from the unaffected side (contralateral/left), thereby maintaining symmetry of analysis and data display between the two hemispheres.

FIG. 15 provides a basic overview of signal processing and display associated with the system. The raw electrical signals are sent over the connection cable (1500) to the interface element (1510), which contains signal amplifiers, basic filters, and analog-to-digital processing functions. The digitized signals are then sent to a processor element (1520) that performs an initial function to organize and interpret the signal data by a particular montage as predetermined for a particular array configuration as identified by the clinician user for the individual patient (1530). The data path so identified is continuously interrogated by a signal analysis function (1540) which utilizes a series of quality control measures to identify "good" and "bad" (bad), if any, recording elements. In the event that no bad recording elements are identified, the processor provides "true" data for review and quantitative analysis (1550), while displaying a "true" reference EEG signal and a "true" synthetic bipolar channel derived from the input channel (1560). Where the quality control element (1540) identifies "bad" contacts (1560), the associated reference EEG signal and associated synthetic channel are modified by the processor to exclude data derived from the "bad" contacts and the matching channel (1570) on the contralateral array to provide "modified" reference EEG data and "modified" synthetic bipolar channel (1580). The data from the "real" analysis or the "modified" analysis can thus be used for subsequent effective symmetry analysis between the two hemispheres (1590).

Detailed Description

The following definitions are provided for specific terms used in the following written description.

Definition of

As used in the specification and in the claims, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

The invention can "comprise" (open) or "consist essentially of" the components of the invention. As used herein, "comprising" means the recited elements or their structural or functional equivalents, plus any other element or elements not recited. The terms "having" and "including" are to be construed as open-ended, unless the context suggests otherwise.

The term "about" or "approximately" means within an acceptable range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, "about" can mean a range of up to 20%, preferably up to 10%, more preferably up to 5%, and still more preferably up to 1% of a given value. Alternatively, particularly with respect to biological systems or processes, the term can mean within one order of magnitude, preferably within 5-fold, and more preferably within 2-fold of the value. Unless otherwise stated, the term "about" means within an acceptable error range of a particular value, such as ± 1-20%, preferably ± 1-10%, and more preferably ± 1-5%. In even further embodiments, "about" should be understood to mean +/-5%.

Where a range of values is provided, it is understood that each intervening value, to the extent that there is no such stated or intervening value, to the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where it is stated that a range includes one or both of the limits, ranges excluding any two of those included limits are also included in the invention.

All ranges recited herein are inclusive of the endpoints, including those endpoints that are recited in ranges "between" two values. Terms such as "about," "generally," "substantially," "about," and the like, are to be construed as modifying a term or value such that it is not absolute, but not read in the prior art. Such terms will be defined by the context and terms they modify, as those terms are understood by those skilled in the art. This includes at least the degree of expected experimental, technical, and instrumental error for a given technique of measurement.

As used herein, the term "and/or," when used in a list of two or more items, means that any one of the recited features can be present, or any combination of two or more of the recited features can be present. For example, if a composition is described as comprising characteristics A, B and/or C, the composition can comprise only a feature; only B; only C; a and B in combination; a and C in combination; b and C in combination; or A, B in combination with C.

As used herein, the term "determining" encompasses a wide variety of actions. For example, "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Additionally, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Additionally, "determining" may include resolving, selecting, choosing, establishing, and the like.

As used herein, "implantable subcorneal electrode array," "implantable electrode array," and "implantable array" are used interchangeably. The implantable electrode array is designed to pass through the skin and be implanted into the sub-aponeurotic space. The implantable electrode array includes one or more recording elements, a reference element, and a ground element. These elements may be constructed of metal, plastic or other compounds.

As used herein, a "reference element" refers to a contact (preferably also made of metal) designed to serve as a common member of a variable electrode pair as a control that allows comparison of subcalotte brain activity detected by one or more recording elements on an implantable array. For example, the reference sensor can allow for comparison of subcalotte brain activity detected by multiple recording elements.

As used herein, "ground element" refers to a recording element used to provide information about globally recorded electrical signals that are from non-physiological sources (such as local electrical devices) and thus allow for common mode rejection of such non-physiological signals.

As used herein, a "recording element" is a contact capable of detecting sub-calophyllal brain electrical activity. Preferably, the recording element is metallic.

As used herein, "subtropical space" refers to the anatomical chamber of the scalp that is located beneath the epidermis and the aponeurosis (the fascia layer of the scalp) and the periosteum and bones of the skull. The subtropical space is a naturally occurring avascular region that can be easily accessed and navigated using specialized tools without the risk of significant injury, bleeding, intracranial infection, or other major medical complications.

As used herein, "support structure" refers to the following structure: (a) capable of accommodating a reference element, a ground element and a recording element; (b) capable of sending electrical signals generated by the brain to an associated processor; and (c) capable of being inserted through the skin and maintained in the sub-calophyllal space. The support structure may be designed for tunneling through a single piece of equipment passing through the sub-aponeurosis space, or the support structure itself may contain the necessary elements to allow independent passage.

As used herein, "circumferentially arranged" is defined as being completely wound around the support structure such that geographically specific electrical signals (e.g., those originating only on one side of the array) can be recorded regardless of the rotational orientation of the array relative to the electrical signals. This thus allows for an omnidirectional registration with optimal tissue contact and/or eliminates the need for a specific orientation of the device within the sub-calophyllal space.

As used herein, "directed tunneling" refers to passing through an array from a particular entry point in an anatomically relevant manner to allow the recording of brain signals of interest. For example, an array directionally tunneling from the posterior of the head to the anterior of the head (i.e., a parasagittal plane) would allow recording of the frontal and parietal lobes, whereas an array directionally tunneling from the medial side of the head to the lateral side of the head (i.e., a coronal plane) would allow recording from a single lobe (e.g., frontal, parietal lobes) in isolation according to the anterior/posterior position of the trajectory.

As used herein, "array exit point" refers to the point on the scalp where the electrode array exits the sub-aponeurotic space, traverses overlying tissue, and exits the scalp to the external environment.

As used herein, a "contralateral array" refers to an array that is implanted on the opposite side of the head from the array of interest (which is conventionally referred to as an ipsilateral array).

As used herein, "sheath" refers to a hollow structure of diameter designed to accommodate an electrode array, which allows the array to pass through the subtropical space of the calotte with minimal trauma to surrounding tissue and the array itself. The sheath may be made of flexible plastic (e.g., silicone rubber or polyurethane), metal, or another material and may be disposable or reusable. The sheath may be cylindrical to allow non-invasive penetration through the tissue of the scalp, but other configurations may be employed to accommodate alternative array designs.

As used herein, "needle" refers to a piece of hardware with a sharp appearance that is designed to penetrate the scalp in a minimally invasive manner. The tip may taper to a point to minimize "cuts" or tears of the scalp and to minimize the resulting size of the entry or exit point from the scalp. The needles may be cylindrical to minimize damage to the tissue of the scalp, but other specific configurations may be employed in connection with the design of a particular array or associated sheath. The diameter may range from as small as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0mm up to 1cm, 2cm or 3 cm. The origin of the needle may be metal or plastic and be sufficiently stiff to allow directional tunneling but may be sufficiently flexible such that shaping of the needle prior to or during insertion allows the individual skull to optimally pass through in a natural curvature. The needle may include improvements that facilitate passage through the tissue of the scalp, such as a removable attachment that can enhance the clinician's ability to "push" or "pull" the needle through the tissue of the scalp.

As used herein, "insertion guide" refers to a structure capable of identifying an area anatomically suitable for electrode access. For example, an array intended to be inserted in a parasagittal plane above the watershed region overlying the main vascular regions of the frontal and apical lobes would be best placed in a line externally continuous with the pupil or transverse canthus of the eye. In this case, the insertion guide would allow the user to identify the linear orientation of the proposed entry and exit points along this line on the scalp. In addition, the insertion guide may provide the clinician with a reference point for optimal insertion and electrode points of the array based on the natural points of curvature of the human skull, particularly at the mid-wall and mid-frontal regions.

As used herein, "retention device," "retention apparatus," or "retention element" refers to a structure that is permanently or temporarily attached to an implantable electrode array that can be secured to the skin or otherwise positioned to prevent the array from falling or pulling out of the skin at an exit site. With some embodiments of the invention, the retaining device can be easily removed to facilitate bedside removal of the array. Such retention devices can be positioned at the skin entry site or exit site (or both) and ensure proper placement and positioning of the implantable device. Examples of such retaining means include, but are not limited to: 1) a plastic "stopper" attached to the end of the array that can cover the access site, attached to the skin and firmly fixing the array against further forward movement; or 2) a plastic disc that can be placed over the array such that the array is restrained from movement by friction and can be secured to the scalp to prevent the array from moving back into the sub-aponeurotic space. In addition, the retention device can be used to cover the insertion and exit points and provide greater sterility of the array within the subcutaneous tissue. The retaining means may be permanently attached to the array (e.g. physically part of the support structure) or applied separately to the array during or during the insertion process. The holding device may also be integrated with the interface and/or the processor such that the interface and/or the processor are included as part of the holding device.

As used herein, "exit guide" refers to a structure used to "grab" the needle and/or sheath to optimize the exit of the array from the subacapular space to the external environment from the preferred exit point. The exit guide can allow the clinician to target a particular exit point on the scalp and provide a physical means to physically align the needle and/or sheath with the predetermined exit point. This can be achieved by combining the pressure on the scalp from the exit guide around the proposed exit point with a central area in the exit guide that contains the proposed exit point with no pressure on the underlying scalp. The shape of the exit guide may be circular due to the central hollow area through which the needle, sheath and/or array pass. The exit guide may be circumferentially tapered toward the central hollow region to assist the needle in passing through the skin.

As used herein, "montage" refers to a particular way of displaying a recorded electrical signal. The montage may be predetermined by the processor or may be user defined. The montage can be modified to include recordings from particular pairs of electrodes of interest and may display an electrical signal as originally recorded ("reference channel") or a signal generated by a quadratic mathematical combination of reference recordings ("synthetic channel"). In this manner, "recording montage" or "reference montage" refers to the signals derived in an original manner based on the particular relative positions of the recording elements and the reference electrodes and the relative orientation of the individual recording elements along the array, whereas "bipolar montage" is a display utilizing mathematical comparisons of reference recordings from individual recording elements of interest along one or more arrays.

As used herein, a "processor" is capable of modifying, analyzing, correlating, storing and displaying recorded subhatic brain electrical activity. The processor may include hardware and/or software elements.

As used herein, "subcalotenoid brain activity" is defined as electrical signals generated by the brain recorded from within the subcalotenoid compartment of the brain. As described herein, "subcalotenoid brain activity" or "subcalotenoid brain activity" can be measured by a variety of different parameters capable of detecting and/or measuring electrical activity, including but not limited to: (a) an average voltage level; (b) a root mean square (rms) voltage level and/or a peak voltage level; (c) derivatives of a Fast Fourier Transform (FFT) involving recorded brain activity, possibly including spectrogram, spectral edge, peak, phase spectrogram, power or power ratio; also includes changes in the calculated power, such as average power level, rms power level, and/or peak power level; (d) metrics derived from spectral analysis such as power spectral analysis, bispectrum analysis, density, coherence, signal correlation, and convolution; (e) a metric derived from signal modeling, such as linear predictive modeling or autoregressive modeling; (f) integrating the amplitude; (g) peak envelope or amplitude peak envelope; (h) a periodic evolution; (i) the inhibition ratio; (j) coherence such as a spectrogram, spectral edges, peaks, phase spectrogram, calculated values of power and/or power ratio; (k) wavelet transforms of recorded electrical signals including spectrograms, spectral edges, peaks, phase spectrograms, power or power ratios of measured brain activity; (l) Wavelet atoms; (m) bispectrum, autocorrelation, cross bispectrum, or cross-correlation analysis; or (n) a waveform phase reversal between the recording element and the reference sensor at a particular time that produces a variable positive or negative value, or other alteration of the dipole-related waveform characteristics. In a preferred embodiment, the subvalvular brain activity is measured by categorical measurements, for example in terms of volts (V), hertz (Hz) and/or derivatives and/or ratios thereof.

As used herein, the system is capable of providing information about subcalophyllal brain activity in a "continuous" manner and/or in a "real-time" manner, thereby allowing for optimal detection of brain activity.

As used herein, implantable subgaleal arrays are designed for temporary (i.e., minutes to hours), acute (i.e., hours to days), or semi-chronic (i.e., days to weeks) implantation in a patient.

As used herein, a recording element may be positioned "in proximity" to other elements on the implantable array. "and.. proximate" is defined as "at," "within," or "associated with" a specified element.

It will be further understood that when an element is referred to as being "on," "attached," "connected" or "coupled" to another element, it can be directly on or over the other element or connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being "directly on," "directly attached to," "directly connected to" or "directly coupled to" another element, there are no intervening elements present. Other words used to describe the relationship between elements (e.g., "between" versus "directly between.. versus," adjacent "versus" directly adjacent, "etc.) should be interpreted in a similar manner.

Spatially relative terms such as "below," "lower," "above," "upper," and the like may be used to describe one element and/or feature's relationship to another element and/or feature as illustrated, for example, in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the system in use and/or operation in addition to the orientation depicted in the figures. For example, if the system in the figures is turned over, elements described as "below" and/or "beneath" other elements or features would then be oriented "above" the other elements or features. The system can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

An array of under-aponeurosis electrodes may be implanted.

We have developed systems and methods that can be used by clinical personnel to insert an implantable sub-calotenoid electrode array into the patient's sub-calotenoid space at the bedside to provide continuous high fidelity EEG recording. Examples have been provided in the figures as described above.

In further examples (not shown), the reference element and/or ground element may be in the form of wires extending longitudinally along the array.

An array such as the array (250) shown in fig. 2 is specifically configured and positioned to collect hemispherical EEG data, i.e., the ability to correlate with brain injury patients. An associated external processor element, such as the processor element (1520) shown in fig. 15, can be configured to record aspects of the array, including the pre-assignment of ground and reference electrodes. Such a configuration can minimize the need for technical expertise in initiating and maintaining records derived from the array, and in some cases, can limit the number of wires associated with the patient. In a preferred embodiment, the system automatically monitors the fidelity of the signals from the individual recording elements to ensure that the recorded electrical activity is valid. In the case of a deployed bilateral array, the system will "balance" the recording montage if there are specific non-functional recording elements on one side or the other that may affect the evaluation of EEG symmetry between the two hemispheres of the brain.

The method of placing the array in the sub-aponeurotic space takes advantage of the specific characteristics of this anatomical location in order to temporarily align the device in a clinical setting by personnel without specialized surgical training or a priori experience of electrode implantation. There are no major blood vessels or other sensitive tissues in this area that could damage and produce clinical complications. In a preferred embodiment, the method does not require an incision, as the array can be implanted into the sub-calophyllal space using a needle, thus limiting the risk of infection associated with device placement. In this embodiment, since the insertion technique only requires the placement of the array of needles, the patient need not be brought to the operating room for device insertion, allowing the procedure to be performed at the bedside in an intensive care unit, in an emergency room, on an emergency road to a hospital, or at the patient's home, etc. In other preferred embodiments, the use of a needle and associated sheath to pass the electrodes through the skin minimizes trauma to the penetrating tissue and minimizes the chance of sub-calophyllal "pocket" formation (resulting in potentially poor contact of the electrode array with the surrounding tissue) as may occur with larger trocars.

Other benefits of the use of an implantable subcofacility electrode array as described herein include a low risk of developing a systemic infection if there is a localized infection of the implanted array, since no main fluid compartment (such as cerebrospinal fluid) or intravascular space is involved. In the event of a suspected local infection, the insertion and stabilization method allows for easy bedside removal of the device without the need for a formal surgical procedure. The presence of the underlying skull prevents any possibility of brain damage during insertion. The natural plane of separation between the aponeurosis and the underlying skull allows the device to pass easily in this plane, thus requiring no special anatomical knowledge or surgical training.

Furthermore, insertion of the implantable electrode array into the sub-calotte space takes advantage of the conservative similarities in human craniocerebral anatomy, particularly the orientation of the largest lobes of the brain (frontal and parietal lobes), the details of the cranial proportion, and the commonality of the major regions of blood supply. Positioning the implantable array as described herein provides coverage of the lateral mass of the frontal and parietal lobes, which is typically the "watershed" region between the major blood vessels supplying most of the brain (the forebrain and middle brain arteries). This is the region where the risk of metabolism is greatest and therefore of most interest for EEG monitoring in situations where blood flow is reduced due to inherent restriction of blood flow.

Means for implanting and maintaining an implantable array.

As described herein, the implantable electrode array is designed for insertion by clinical personnel at the bedside without specialized surgical expertise. Furthermore, in a preferred embodiment, the described array is designed for temporary use (e.g., lasting minutes to weeks), can be easily removed at the bedside (e.g., without clinical indication of sub-capitate EEG recording anymore), and can be inserted into the patient with minimal risk using only local anesthetics, as placed outside the skull, no major anatomical structures are threatened, and the array is not placed within access to blood or other fluid compartments with physiological extension to the human body or brain.

In a preferred embodiment, the implantable array is designed to pass in a linear parasagittal plane with anterior-posterior orientation according to the ipsilateral pupillary line to allow for anatomically relevant hemispheric monitoring. In such cases, an "insertion" guide will help the clinician determine the entry and exit points for the array and optimize the positioning of subsequent electrodes in the parasagittal line of interest before passing the array through the sub-calotenoid space. In some cases, the insertion guide may be an L-shaped tool with a 90 degree elbow designed to be placed on the skull in line with the pupillary line, which would allow the clinician to 1) confirm the planned trajectory of the implanted array, 2) mark the entry point at the wall or forehead bend of the skull (which would be identified on the scalp as representing a point at 45 degrees to the elbow of the insertion guide), and 3) mark the proposed exit point at the extra view of the scalp, which would allow the entire length of the implanted array to reside within the subcaloid space (based on the known length of the array itself). Fig. 7A and 7B show an example of such a tool in the form of a needle insertion guide (750).

In other preferred embodiments, the system includes additional hardware for rationalizing and simplifying the insertion technique. For example, the system may include needles for delivering an implantable array into the sub-aponeurotic space, such asneedles 300, 320 and 330 shown in fig. 3A, 3B and 3C. In such embodiments, the needle may have a tapered tip to minimize damage to the skin and subcutaneous tissue. The needles may also have a bend at the tip to facilitate access to the subcalotte space, and there may be a hollow sheath attached to the needles that passes the array to be deployed in the subcalotte space. In some embodiments, the needle may be inserted at one point and exit at a second point or it may be hollow and enter only to deposit the array within the sub-aponeurosis space. Additionally, the array may include temporary plastic "detents" to be placed at the entry and/or exit points to secure the implantable array to the skin. Such actuators may also include an interface and/or a processor. In some embodiments, the needle may have a removable ledge that aids in the pushing and pulling aspects of the insertion process.

In some cases, such as where a shorter array might be used, it may be deployed using a hollow needle where there is a single insertion point without a secondary exit through the skin; in which case the needle would be passed into the sub-aponeurotic space and the implantable electrode array inserted through the needle, with the needle then withdrawn over the electrode array and then the brake applied to secure the electrode in place.

Other preferred embodiments include an "exit guide" that helps the clinician locate and optimize the needle, sheath, and/or array across the scalp from the desired exit point. An example of such anexit guide 600 is provided in fig. 6A.

Associated hardware

In a preferred embodiment, a single lead from each implantable electrode array can be connected to external hardware to amplify/digitize/filter the recorded EEG signals.

As described herein, the connected processor is capable of recording, analyzing and displaying the raw EEG signals from the array.

In a preferred embodiment, the processor comprises a predetermined "template" that the user can select according to the particular properties of the array implanted in a particular patient (unilateral, bilateral, etc.) and that is critical to identifying the appropriate reference element, ground element, and recording element. For example, where a double-sided subcalotte array is deployed and the user selects the appropriate template, the ground element may be identified by the processor as the furthest contact on one array from the exit point of the array, whereas the reference is the furthest contact on the other array. In another representative example where a single-sided under-the-hat aponeurosis array may be deployed, the template may identify the ground element as the closest contact to the exit point of the array and the reference element as the closest contact to the exit point of the array. In other embodiments, templates specific to arrays containing different numbers of recording elements with different pitches between recording elements may be available. The presence of these templates thus allows the user to avoid the need to enter details of ground elements, reference elements or registration elements on a patient-by-patient or array-by-array basis. More specifically, this allows the user to have no expertise or technical skills in EEG technology to provide a durable and effective functional EEG recording from the sub-galenical array.

In a further preferred embodiment, the processor includes a real-time analysis function that interrogates the quality of the electrical signals from the individual recording elements on the array to confirm the accuracy of the recording, and if an adverse signal is recorded (i.e., extremely low amplitude indicates lack of contact with tissue or an incorrectly connected array, or extremely high amplitude indicates electrical artifacts generated by non-physiological sources), the processor identifies the contact as a "bad channel". The user can thus be alerted to pursue simple intervention to ensure that the arrays of interest are properly connected. In other cases, the processor will automatically switch use of the recording element to the recording element that provides the electrophysiologically appropriate signal. With this continuous monitoring and potential switching activity, the processor thus 1) provides an immediate and automated method to confirm the high fidelity reference and ground channels necessary for effective EEG recording; 2) allowing the user to have no technical expertise or experience with EEG recordings; and 3) automatically maintain maximum fidelity of the EEG recording throughout the recording without the need to replace or monitor the fidelity of the reference or ground leads or specific recording elements along the array.

In some cases, the processor may display and store EEG data in a bipolar reference montage, thereby mathematically comparing adjacent contacts to provide a bipolar reference for analysis. In some cases bipolar reference comparisons may use a "skip one", "skip two", or "skip more" approach to provide greater geographic coverage of the underlying brain. Such a bipolar comparison is generated by a mathematical combination of reference recordings from particular recording elements (i.e., common reference recordings) to derive a composite electrical signal representing the difference in electrical activity in the geographic region of the brain subtended by the two recording elements included in the bipolar comparison.

In additional embodiments, the processor will include analysis functions that perform automated quantitative analysis of the recorded EEG signals; such analysis may include derivatives of a Fast Fourier Transform (FFT) involving recorded brain activity, possibly including spectrograms, spectral edges, peaks, phase spectrograms, power or power ratios; also include changes in calculated power such as average power level, rms power level, and/or peak power level; metrics derived from spectral analysis such as power spectral analysis, bispectrum analysis, density, coherence, signal correlation, and convolution; a metric derived from signal modeling, such as linear predictive modeling or autoregressive modeling; integrating the amplitude; peak envelope or amplitude peak envelope; a periodic evolution; the inhibition ratio; correlation and phase delay; wavelet transforms of recorded electrical signals including spectrograms, spectral edges, peaks, phase spectrograms, power or power ratios of measured brain activity; wavelet atoms; bispectrum, autocorrelation, cross bispectrum, or cross-correlation analysis; data derived from a neural network, a recurrent neural network, or a deep learning technique; or an identification of a region of the array that detects a local minimum or maximum of a parameter derived from any of the above.

In the case of bilateral monitoring, the processor will also include a "balancing" function that includes and displays equivalent channels from each array to provide symmetric data for each hemisphere of the brain. Maintaining symmetry in data acquisition and display may be critical when a clinician desires to compare aggregate electrical activity on both sides of the brain in order to identify possible asymmetries in the electrical activity. For example, in the case where an injury or neurophysiologic distortion may affect one side of the brain ("unilateral abnormality"), there may be diminished or otherwise altered brain electrical activity in the affected hemisphere as compared to the contralateral ("unaffected") hemisphere. In contrast, where both hemispheres are affected by injury or physiological distortion in an equivalent manner ("bilateral abnormalities"), it would be expected that the signals from both hemispheres would be symmetrically reduced. However, such analysis requires that the nature of the source data be equivalent between the two hemispheres (e.g., data recorded from the same anatomical location and electrophotographic "field"); any asymmetry in electrode position or distance may lead to spurious comparisons. In the event that the processor can exclude a particular recording element on one array, the "balance" function of the processor will similarly exclude data from matching recording elements on the opposite array to ensure symmetry of the data input for subsequent analysis.

The present invention is not limited to the embodiments described herein before, which may vary in construction and detail without departing from the spirit of the invention. The entire teachings of any patent, patent application, or other publication cited herein are incorporated by reference as if fully set forth herein.

Claims (14)

Translated fromChinese

1.一种包括能够被植入在帽状腱膜下空间中并且包括至少两个元件的支撑结构的可植入帽状腱膜下电极阵列，所述元件中的至少一个是记录元件，所述可植入帽状腱膜下电极阵列结合至少一个参考元件和至少一个地元件能够检测和/或发送帽状腱膜下电信号。1. An implantable subgaleal electrode array comprising a support structure capable of being implanted in the subgaleal space and comprising at least two elements, at least one of the elements being a recording element, wherein The implantable subgaleal electrode array in combination with at least one reference element and at least one ground element is capable of detecting and/or transmitting subgaleal electrical signals.2.根据权利要求1所述的电极阵列，其中，所述阵列的至少两个元件包括地元件。2. The electrode array of claim 1, wherein at least two elements of the array comprise ground elements.3.根据权利要求2所述的电极阵列，其中，所述至少两个元件或所述阵列包括参考元件。3. The electrode array of claim 2, wherein the at least two elements or the array includes a reference element.4.一种可植入帽状腱膜下电极阵列，所述可植入帽状腱膜下电极阵列包括能够被植入在所述帽状腱膜下空间中的支撑结构并且包括：4. An implantable subgaleal electrode array comprising a support structure capable of being implanted in the subgaleal space and comprising:(a)至少一个参考元件；(a) at least one reference element;(b)至少一个地元件；以及(b) at least one ground element; and(c)一个或多个记录元件；以及(c) one or more recording elements; and其中，所述阵列能够检测和/或发送帽状腱膜下电信号。Wherein, the array is capable of detecting and/or transmitting subgaleal electrical signals.5.根据权利要求3或4所述的电极阵列，其中：5. The electrode array of claim 3 or 4, wherein:(a)所述记录元件沿着所述支撑结构线性地布置；(a) the recording elements are arranged linearly along the support structure;(b)所述记录元件被周向地布置到所述支撑结构；(b) the recording elements are arranged circumferentially to the support structure;(c)所述参考元件和所述地元件位于离阵列出口点最远的触点处；(c) the reference element and the ground element are located at the contacts furthest from the array exit point;(d)所述参考元件和/或所述地元件位于阵列出口点近侧；(d) the reference element and/or the ground element are located proximal to the exit point of the array;(e)所述参考元件和/或所述地元件沿着所述阵列分布；(e) the reference elements and/or the ground elements are distributed along the array;(f)所述参考元件和所述地元件位于对侧阵列上或并置在同一阵列上；(f) the reference element and the ground element are located on opposite arrays or juxtaposed on the same array;(g)所述参考元件包括所述地元件；(g) the reference element includes the ground element;或者or(h)(a)-(g)的任何组合。(h) Any combination of (a)-(g).6.根据权利要求4或6所述的电极阵列，其中，所述支撑结构：6. The electrode array of claim 4 or 6, wherein the support structure:(a)是圆柱形的形状；(a) is cylindrical in shape;(b)由柔性材料制成；和/或(b) made of flexible material; and/or(c)以具有尖端的形状弯曲；以及(c) curved in a shape with a pointed tip; and(d)(a)-(c)的任何组合。(d) Any combination of (a)-(c).7.根据权利要求4-6中的任一项所述的电极阵列，其中，所述电极阵列还包括：7. The electrode array of any of claims 4-6, wherein the electrode array further comprises:(a)护套；(a) sheath;(b)针和附接装置，其中，所述附接装置能够推动和/或拉动所述针穿过所述帽状腱膜下空间；(b) a needle and attachment means, wherein the attachment means is capable of pushing and/or pulling the needle through the subgaleal space;(d)用于标识解剖学适于电极进入的区域的插入导向件；(d) an insertion guide for identifying areas anatomically suitable for electrode entry;(e)所述电极在皮肤入口部位处的保持装置；(e) a holding device for the electrode at the skin entry site;(f)所述电极在皮肤出口部位处的保持装置；(f) retention means for said electrodes at the skin exit site;(g)隧穿装置；(g) tunneling devices;(h)用于方便针在出口点处穿过所述皮肤的出口导向件；(h) an exit guide for facilitating passage of the needle through the skin at the exit point;(i)与所述电极阵列的一部分物理上相关联、连接或者以其他方式连接到所述电极阵列的一部分的针；或(i) a needle physically associated with, connected to, or otherwise connected to a portion of the electrode array; or(j)(a)-(i)的任何组合。(j) Any combination of (a)-(i).8.一种用于测量帽状腱膜下活动的系统，其中，所述系统包括：8. A system for measuring subgaleal activity, wherein the system comprises:(a)根据权利要求1-4中的任一项所述的可植入帽状腱膜下电极阵列；以及(a) The implantable subgaleal electrode array of any one of claims 1-4; and(b)将所述可植入帽状腱膜下电极阵列连接到处理器的接口。(b) An interface connecting the implantable subgaleal electrode array to a processor.9.根据权利要求8所述的系统，其中，所述处理器被配置成：9. The system of claim 8, wherein the processor is configured to:(a)实时地检测、过滤、处理、显示、存储和/或发送帽状腱膜下电信号；(a) detect, filter, process, display, store and/or transmit subgaleal electrical signals in real time;(b)使对所述参考元件和/或所述地元件的选择自动化；(b) automating the selection of said reference element and/or said ground element;(c)询问所述参考元件、所述地元件和所述记录元件的记录；(c) interrogating the records of the reference element, the ground element and the recording element;(d)过滤和/或处理检测到的电信号以生成单通道或多通道脑电图(EEG)数据，优先地包括：(d) filtering and/or processing detected electrical signals to generate single-channel or multi-channel electroencephalography (EEG) data, preferably including:1.原始EEG数据；或1. Raw EEG data; or2.定量EEG数据；2. Quantitative EEG data;(e)利用一系列显示和记录蒙太奇，包括参考蒙太奇和从电极对导出的蒙太奇；(e) Utilize a series of display and recording montages, including reference montages and montages derived from electrode pairs;(f)将记录蒙太奇预先指派给一个或多个记录元件；(f) pre-assign the recording montage to one or more recording elements;(g)优先地使用诸如以下技术连续地监测、标识和排除演示差信号质量的参考元件、地元件和/或记录元件；(g) preferentially continuously monitor, identify and exclude reference, ground and/or recording elements that demonstrate poor signal quality using techniques such as;1.对绝对电压的评价；1. Evaluation of absolute voltage;2.对相对于其他个别或聚合记录元件的电压的评价；2. Evaluation of the voltage relative to other individual or aggregate recording elements;3.对绝对EEG功率的评价；3. Evaluation of absolute EEG power;4.对相对于其他个别或聚合记录元件的EEG功率的评价；4. Evaluation of EEG power relative to other individual or aggregate recording elements;5.记录元件的阻抗测量；5. Record the impedance measurement of the element;(h)分析和解释多个植入电极阵列之间的信号；(h) analyzing and interpreting signals between multiple implanted electrode arrays;(i)使蒙太奇平衡，优先地通过选择来自特定记录元件的数据以在阵列之间提供对称性；(i) Balancing the montage, preferably by selecting data from particular recording elements to provide symmetry between the arrays;(j)允许多个阵列上的记录元件的特定组合的可变或动态地选择以形成记录或显示蒙太奇；(j) allowing variable or dynamic selection of specific combinations of recording elements on multiple arrays to form a recording or display montage;(k)在阵列上的所述记录元件之间执行双极数学参考；(k) performing bipolar mathematical referencing between the recording elements on the array;(l)能够测量、分析和报告脑的两个半球之间的对称性、不对称性或差异分析；和/或(l) be able to measure, analyze and report the analysis of symmetry, asymmetry or difference between the two hemispheres of the brain; and/or(m)(a)-(l)的任何组合。(m) Any combination of (a)-(l).10.根据权利要求9或9中的任一项所述的系统，其中，所述接口和所述处理器是集成的。10. The system of any of claims 9 or 9, wherein the interface and the processor are integrated.11.根据权利要求8-10中的任一项所述的系统，其中，所述接口和所述处理器是便携式的。11. The system of any of claims 8-10, wherein the interface and the processor are portable.12.一种根据权利要求1-7中的任一项所述的电极阵列或根据权利要求9-11中的任一项所述的系统的用途，其中，所述阵列或系统用于测量选自以下各项的状况：12. Use of an electrode array according to any one of claims 1-7 or a system according to any one of claims 9-11, wherein the array or system is used to measure selected From the following conditions:a.脑损伤；a. Brain damage;b.中风；b. stroke;c.脑出血；c. Cerebral hemorrhage;d.颅内出血；d. Intracranial hemorrhage;e.低氧/缺氧性脑损伤；e. Hypoxic/hypoxic brain injury;f.癫痫发作；f. Seizures;g.临界神经学损伤；和/或g. borderline neurological impairment; and/orh.要求脑监测的医疗状况。h. Medical conditions requiring brain monitoring.13.一种根据权利要求1-7中的任一项所述的电极阵列或根据权利要求9-11中的任一项所述的系统的用途，其中，所述阵列或系统用于：13. Use of an electrode array according to any one of claims 1-7 or a system according to any one of claims 9-11, wherein the array or system is for:a.在血管内过程期间测量脑活动；a. Measurement of brain activity during intravascular procedures;b.在神经外科手术或血管过程期间测量脑活动；b. Measurement of brain activity during neurosurgery or vascular procedures;c.在心脏或其他外科手术过程期间测量脑活动；c. Measurement of brain activity during cardiac or other surgical procedures;d.在急性环境中评估脑损伤；d. Evaluation of brain injury in acute settings;e.标识脑损伤或异常的偏侧性；e. Identification of brain injury or abnormal laterality;f.提供关于脑健康状态的诊断信息；或者f. Provide diagnostic information about the state of brain health; org.(a)-(f)的任何组合。g. Any combination of (a)-(f).14.一种检测和/或发送帽状腱膜下电信号的方法，所述方法包括以下步骤：14. A method of detecting and/or transmitting a subgaleal electrical signal, the method comprising the steps of:(a)在支撑结构内提供可植入电极阵列；(a) providing an array of implantable electrodes within a support structure;(b)选择在患者的皮肤/表皮上解剖学适于所述支撑结构的入口点并且进入患者的帽状腱膜下空间；(b) selecting an anatomically appropriate entry point for the support structure on the patient's skin/epidermal and into the patient's subgaleal space;(c)将所述支撑结构通过所述选择的入口点插入到所述帽状腱膜下空间中并且基本上沿着覆盖在所述患者的脑的一个半球上面的旁矢状面前后线；以及(c) inserting the support structure into the subgaleal space through the selected entry point and substantially along the parasagittal anterior-posterior line overlying one hemisphere of the patient's brain; as well as(d)将处理器对接到所述电极阵列以接收所述帽状腱膜下电信号。(d) docking a processor to the electrode array to receive the subgaleal electrical signal.

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